DIA-CEM is a radiopaque resin cement that can be used in self-cure or light-cure mode. It corresponds to type 2 class 3 of ISO 4049 and contains more than 60% of inorganic filler. DIA-CEM…
DIA-CEM is a radiopaque resin cement that can be used in self-cure or light-cure mode. It corresponds to type 2 class 3 of ISO 4049 and contains more than 60% of inorganic filler. DIA-CEM shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
Record
Regulatory record for DIA-CEM | Listed by | Diadent Group Intl., Inc., Canada |
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-07-20 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry and away from Sunlight; Storage environment temperature 2 to 27 °C |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.